Oxicom 2100
INSTRUCTION MANUAL
IVD 
EC REP
WATERS MEDICAL SYSTEMS P.O. BOX 6117 ROCHESTER, MN 55901-6117 Telephone: (800)-426-9877 (507) 252-3784 Fax: (507) 252-3700
CEpartner4U BV
Esdoornlaan 13 3951DB; Maarn NL. +31 (0) 6-516.536.26
Caution: Federal law restricts this device to sale by or on the order of a physician.
REV 042006
WPN 0000707.000
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WATERS MEDICAL SYSTEMS
Customer Service
Waters Instruments provides toll-free telephone support to assist you with questions both technical and non-technical. Most problems can be diagnosed over the phone; however, if a representative needs to be called we can assist you. The toll-free number is also used to order instruments, parts, disposables and product information. Orders are also placed with a purchase order sent in on the Fax number shown below. When calling with a technicalrelated question, ask for technical support and your call will be directed quickly. All other questions can be directed to customer service.
Customer Service:
800-426-9877 (United States & Canada)
507-252-3784 (International calls)
507-252-3700 (Fax)
Returning Equipment
If we cannot resolve equipment problems over the phone, you may need to return your instrument to Waters. All items to be returned must be issued a RMA (Return Material Authorization) number in advance. This will prevent delays and possible refusal upon delivery. All parcels should be shipped to our street address. Correspondence can be sent to our post office box or use the Fax number above.
Parcels: |
Waters Medical Systems |
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Attn: Medical Systems RMA# |
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2112 15th Street NW |
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ROCHESTER MN 55901 |
Correspondence: |
Waters Medical Systems |
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Attn: Medical Systems |
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P.O. Box 6117 |
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ROCHESTER MN 55903-6117 |
1
WATERS MEDICAL SYSTEMS
QUALITY POLICY
Provide products and services that meet our customer's expectations, are defect free, and are delivered on time.
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TABLE OF CONTENTS
SECTION |
TITLE |
PAGE |
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Customer Support...................................................................................... |
1 |
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1 |
General Information.................................................................................. |
5 |
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1.1 |
Introduction............................................................................................ |
7 |
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1.2 |
Benefits .................................................................................................. |
7 |
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1.3 |
Theory of Operation............................................................................... |
8 |
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1.4 |
Accuracy Limitations............................................................................. |
8 |
2 |
Operating Controls .................................................................................. |
11 |
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2.0 |
Operating Controls............................................................................... |
13 |
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2.1 |
Front Panel Controls ............................................................................ |
13 |
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2.2 |
Back Panel Controls............................................................................. |
14 |
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2.3 |
DC-80 Disposable Cuvette .................................................................. |
14 |
3 |
Operating Instructions ............................................................................ |
15 |
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3.1 |
Sample Preparation & Blood Handling ............................................... |
17 |
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3.2 Power On & Warm-up ......................................................................... |
19 |
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3.3 |
Quality Control .................................................................................... |
20 |
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3.4 |
O2 Saturation Mode.............................................................................. |
28 |
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3.6 |
Heparinize Cuvette............................................................................... |
30 |
4 |
Calibration................................................................................................ |
31 |
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4.1 |
Calibration Theory............................................................................... |
33 |
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4.2 |
Blood Sample Preparation ................................................................... |
34 |
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4.3 |
Determine Functional Oxygen Saturation ........................................... |
37 |
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4.4 |
Calibration............................................................................................ |
38 |
5 |
Maintenance ............................................................................................. |
43 |
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5.1 |
Maintenance Schedule ......................................................................... |
45 |
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5.2 |
Quality Control Filters - Cleaning ....................................................... |
45 |
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5.3 |
Sample Chamber Cleaning .................................................................. |
45 |
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5.4 |
Factory Default Settings ...................................................................... |
46 |
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5.5 |
Error Codes .......................................................................................... |
48 |
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5.6 |
Erroneous Readings ............................................................................. |
51 |
6 |
Appendix................................................................................................... |
54 |
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Oxicom-2100 Specifications...................................................................... |
56 |
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Abbreviations............................................................................................. |
58 |
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Equations.................................................................................................... |
59 |
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Worksheets................................................................................................. |
60 |
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4
SECTION 1
GENERAL INFORMATION
5
SECTION 1 GENERAL INFORMATION
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SECTION 1 GENERAL INFORMATION |
INTRODUCTION |
the cuvette and syringe are disposed with other |
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hospital wastes. |
The Waters Medical Oxicom 2100 Whole Blood Oximeter is designed for today's busy cardiac catheterization laboratory requirements and standards. The Oxicom 2100 will provide accurate, repeatable saturation measurements in less than ten seconds.
The Oxicom 2100 optically measures the light absorption of the blood to measure functional oxygen saturation. Blood is infused into a safe, convenient, single-use, disposable cuvette. No special cleaning solution, calibrator, or tubing is required.
1.2 BENEFITS
The Oxicom 2100 uses the latest fiberoptic technology and a solid state detector to provide accurate and repeatable oxygen saturations. In the oxygen saturation mode, the Oxicom 2100 will provide results in less than 10 seconds.
Contact with blood and contaminated waste products is virtually eliminated with the Oxicom 2100. Blood samples are injected into a sealed, single-use disposable cuvette which is easily inserted into the sample chamber located on the front panel. After the sample is measured,
CAUTION:
Be sure that the cuvette and syringe are disposed of in a manner consistent with good hospital practices for infectious materials.
The introduction of fiberoptic technology has eliminated the need for maintaining tubing or pumps with the Oxicom 2100. No zeroing or calibration solutions are required.
The Quality Control (QC) filters supplied with your Oxicom 2100 allows the user to check the calibration of the Oxicom 2100. The set of filters consist of one translucent plastic filter (QCl), and two precision glass filters (QC2 and QC3).
The optical densities of these filters are stored in the unit's microprocessor. When inserted into the sample chamber the Oxicom 2100 measures the optical density and compares it to the value stored. If the optical densities match the display will read a %Sat value. After affirming that the Oxicom 2100 is calibrated, the unit is ready to use.
Liquid control samples are also available but can not be used to calibrate in place of whole blood.
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SECTION 1 GENERAL INFORMATION
1.3 THEORY OF OPERATION
The Waters Oxicom 2100 is a Whole Blood Oximeter with the capability to measure functional oxygen saturation. The Oxicom 2100 measures functional oxygen saturation of a 0.5 ml sample of whole blood.
The Oxicom 2100 uses a silicon photodetector and light emitting diodes (LED) mounted in a sealed housing within the instrument. The blood sample is contained in an optically clear, disposable cuvette. The bloodfilled cuvette is inserted through the front of the instrument into the sample chamber housing. BLOOD IS NOT INFUSED INTO THE UNIT.
The optical density of the sample is measured using two pulsed LEDs and one photodiode. The Oxicom 2100 system is designed to pulse on the infrared (IR) LED, and measure the optical density at 805 nm (nanometers). Alternately, the red LED is turned on and measures the optical density at 660 nm. The photodiode converts the light transmitted through the blood filled cuvette into a current proportional to the amount of incident light. The current is processed by the microprocessor and the functional %O2SAT is calculated by the Oxicom 2100.
The amount of IR light absorbed by the blood is relatively independent of the blood's oxygenation. However, RED light absorption or optical density , is strongly dependent on the oxygen saturation. The ratio of the optical densities at the two wavelengths is used to calculate the functional oxygen saturation.
1.4 ACCURACY LIMITATIONS
LIPID SAMPLES:
Lipid (fat) particles in a blood sample may distort the normal light scattering and cause erratic readings.
HEPARIN AND SALINE:
Excess heparin and saline dilutes and lowers the hemoglobin of the sample. This artificially raises the percent saturation reading of the sample and can cause separation which further raise the percent saturation reading. Experience
indicates samples with 10% or more liquid heparin or saline will affect the reading. Prior to withdrawing a sample of blood from any arterial line, the operator should aspirate 3-5 cc of blood from the line to remove any residual heparin or saline.
AIR BUBBLES:
Care should be taken to prevent oxygenation of the sample, always point the syringe and cuvette up. If micro bubbles are present, the oxygen saturation of the sample tends to rise 1- 2%.
INTERFERING DYES:
Indocyanine (Cardio) Green, Evans Blue and Methylene Blue dyes absorb light at the same frequencies as blood. The presence of these dyes will effect oxygen saturation readings of the Oxicom 2100. Studies using interfering dyes must be run after blood samples have been taken to avoid erroneous readings.
OLD BLOOD SAMPLES:
Inserting the cuvette into the sample chamber within 10 minutes is recommended. If a delay is anticipated and clotting may begin, the syringe should be pre-coated with heparin.
CUVETTE HANDLING:
Care must be taken not to contaminate the optical path of the cuvette. Do not reuse cuvettes or the white plugs. Do not lay the cuvette on edge; this will increase the chance of blood separation. The clear sampling area should be laid face down.
CARBOXYHEMOGLOBIN and METHEMOGLOBIN:
The Oxicom 2100 is an oximeter which uses two wavelengths to determine the Functional Oxygen Saturation. Two wavelength oximeters such as the Oxicom 2100 cannot determine the
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SECTION 1 GENERAL INFORMATION |
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amount of |
carboxyhemoglobin |
or |
oxyhemoglobin as it relates to the total |
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methemoglobin. |
They can |
only |
hemoglobin available for oxygenation. |
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determine |
the |
percentage |
of |
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SECTION 2
OPERATING CONTROLS
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SECTION 2 OPERATING CONTROLS
Oxicom 2100 Front Panel
Operating Controls
Figure 2.1
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SECTION 2 OPERATING CONTROLS
2.0OPERATING CONTROLS
This section describes the controls, displays and markings on the Oxicom 2100.
2.1 FRONT PANEL CONTROLS
DISPLAY: The measurement display consists of a three character display with two decimal points. Whenever the decimal points alternate positions the Oxicom 2100 is processing information. The display provides the user with the following information.
WRM - WaRM-up indicates that the Oxicom 2100 is in the timed 15 minute warm-up period.
RDY - ReaDY indicates the Oxicom 2100 is ready to accept blood samples. If the unit has been turned off and on again, you may bypass the warm-up by waiting 10 seconds and pressing START.
INS - INSert instructs the operator to insert the cuvette.
RMV - ReMoVe, instructs the user to remove the cuvette or Quality Control Filters from the sample chamber.
ER1 - ER9 & ERa - ERe - ERror Codes l - 9 and a - e indicate the Oxicom 2100 was unable to measure the blood samples. Refer to Section 5.4 for more information.
* - The * symbol followed by any number indicates that the %SAT value to be displayed exceeds 99.9%. Example: If
the display reads *2.4 the actual value is 102.4.
Decimal Point - The two decimal points on the display indicate the magnitude of the reading and will alternately flash at one second intervals during balancing and calibration.
%Sat - % Saturation. The %SAT will light only when the mode switch is in the O2SAT position. The display shows the functional oxygen saturation value of the blood sample.
CAL - The CALibration indicator will be lit when the operator has entered the calibration menu. Refer to the calibration instructions Section 4.
START - The START button is used to initiate blood sample measurements in saturation mode. START also places the Oxicom 2100 in the calibration mode when depressed and the POWER switch is turned on.
Arrow Switches - The Up/Down Arrow switches are functional only in the calibration mode. In the calibration mode, the operator will use the Arrows to adjust the displayed value to the correct functional saturation.
Sample Chamber - The disposable cuvette is inserted into the sample chamber. The display directs the user to INSert the cuvette. DO NOT INJECT BLOOD INTO THE SAMPLE CHAMBER.
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SECTION 2 OPERATING CONTROLS
Oxicom 2100 Back Panel
Operating Controls
Figure 2.2
2.2 BACK PANEL CONTROLS
POWER - Switch applies AC power to the Oxicom 2100. When the Oxicom 2100 is turned On all the indicators on the front panel will do a self test. "WRM" will be displayed when completed.
POWER INPUT: Detachable AC power cord connection.
2.3 DC-80 DISPOSABLE CUVETTE
The DC-80 cuvette is used to hold the blood sample. It is a disposable single use device. Do not reuse the cuvettes or filters. The cuvette has a top and a bottom, a small panel indicates bottom and should always be inserted into the Oxicom downward. The porous filters come with the cuvettes and are to be mounted on the short neck of the cuvette. The filters allow air to pass through when the cuvette are being filled with blood, and prevent blood from spilling from the tip of the cuvette. The filters are also called cuvette caps, caps, or plugs.
Position panel facing down.
Disposable Cuvette and Porous Filters
Figure 2-3
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SECTION 3
OPERATING INSTRUCTIONS
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SECTION 3 OPERATING INSTRUCTIONS
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SECTION 3 OPERATING INSTRUCTIONS
3.1SAMPLE PREPARATION AND BLOOD HANDLING
The Oxicom 2100 requires less than 0.5 cc of blood to measure blood oxygen saturation. The blood sample is withdrawn into a syringe. A disposable cuvette with filter is placed on the syringe. Blood is then infused into the cuvette and the cuvette is inserted into the Oxicom 2100 sampling chamber. Syringes and cuvettes are discarded after the sample has been measured.
The disposable Oxicom 2100 cuvettes are not heparinized. Therefore, the user must take the necessary precautions to prevent the blood sample from clotting. If the oxygen saturation of the blood sample is going to be determined within ten minutes of withdrawing, no heparin is required. If the sample is to be used for calibration of the Oxicom 2100, heparin is recommended, refer to Section 3.7.
For proper measurements, calibration and personal safety, it is essential that you follow these steps consistently.
HELPFUL HINTS:
All samples should be measured within ten minutes of withdrawal. The sooner the samples are measured the less likely the blood cells will separate.
Evacuate any air bubbles that remain in the syringe before mounting the cuvette. Air
bubbles within the cuvette may alter the reading, especially during calibration.
Inspect the cuvette for cleanliness prior to use. Do not touch the sampling area (the clear surface) of the disposable cuvette. Handle the cuvette by their edges or tips.
Do not allow the cuvette to lie on the edge. Position the cuvette on the syringe so that when laid down, one of the cuvette side's face down. This will minimize any cell separation that may occur if the sample is not measured after withdrawal.
Place the porous filter (white plug) onto the disposable cuvette before infusing the blood from the syringe, except when calibrating the Oxicom 2100.
Do not force the blood sample into the cuvette. If a resistance is felt, discard and try another cuvette and filter.
Do not allow the filters to come in contact with any fluid prior to mounting on cuvette.
Do not reuse cuvettes or white plugs. The sample must be mixed prior to
inserting into the Oxicom 2100.
Samples diluted with saline or heparin will cause erroneous readings. All residual saline or heparin must be removed from the line before aspirating into the sample syringe.
Cardiogreen dye and other dyes will affect the oxygen saturation reading. All saturation measurements must be made before dye injections are made.
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SECTION 3 OPERATING INSTRUCTIONS
SUPPLIES:
Disposable cuvette, one for each sample. Porous filter, one for each cuvette. Syringe, one for each sample.
Tissues or 4x4 gauze.
PROCEDURE
1. Prepare the cuvette and filters by mounting the filters onto the short end of the cuvette.
Bottom panel (Always position down)
2.Flush or withdraw enough blood from the patient line in order to remove any saline. If the line is not properly flushed the sample will be contaminated and poor readings will result.
3.Withdraw 1 to 2 cc of blood from the line into the syringe. Evacuate any air bubbles that may be in the sample . If necessary, gently tap the syringe to knock any air bubbles loose.
4. Mount and secure the long end of the cuvette onto the syringe.
5.Holding the cuvette and syringe vertically, slowly infuse the blood into the cuvette. Do not allow any air bubbles to adhere to the internal surface of the cuvette. Gently tap the cuvette if bubbles begin to develop.
6.The sample should be mixed by rolling the syringe between your hands in a horizontal position.
7.Proceed to Section 3.2 for instructions on measuring a blood sample.
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